PHANTOM CS DISTRACTION SCREW — Class II medical device recall Z-2527-2020
Terminated recall by TeDan Surgical Innovations LLC, reported 2020-07-15, distributed nationwide. Lack of pouch seal. Product is labelled as sterile.
| Recall number | Z-2527-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TeDan Surgical Innovations LLC, Sugar Land, TX, United States |
| Recall initiated | 2020-05-15 |
| Classified | 2020-07-07 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2022-09-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, FR, GB, PH, TW |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00851797006450 |
| Lot numbers | 2018020801, 2018061101 |
Product
PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Reason for recall
Lack of pouch seal. Product is labelled as sterile.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2527-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.